GC Labs Faces One-Month Certification Revocation After Specimen Mix-Up Leads to Unnecessary Mastectomy

김영택 기자 / approved : 2025-08-04 03:32:12
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Photo courtesy of Yonhap News

 

 

[Alpha Biz= Kim YoungTaek] The Ministry of Health and Welfare of Korea has revoked GC Labs’ pathology certification for one month after the company’s mishandling of test specimens led to a 30-year-old woman undergoing an unnecessary breast removal surgery.



The decision was made by the Specimen Testing Certification Management Committee, following an on-site inspection by the Korean Society of Pathologists.



GC Labs, which handles outsourced tissue analyses, admitted that a labeling error during slide preparation caused one patient’s test result to be mistakenly assigned to another woman. As a result, the patient—identified only as “A”—underwent partial mastectomy in September 2024, only to discover afterward that she did not have cancer.



Authorities determined that GC Labs’ inadequate corrective measures and the serious harm to the patient warranted the temporary certification cancellation.



During the suspension, GC Labs will be barred from conducting pathology tests or billing for related health insurance claims.



“This incident is a grave matter directly tied to public health and safety,” said Lee Jung-kyu, Director of Health Insurance Policy at the Ministry. “We will pursue systemic improvements to prevent such errors from recurring.”



The ministry added that the case will serve as a catalyst to strengthen oversight across all stages of specimen handling and testing nationwide.
 

 

 

 

Alphabiz 김영택 기자(sitory0103@alphabiz.co.kr)

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